Kornimate/medical-research-clean huggingface dataset:
cryolipolysis for jawline contouring

Conditions: Body Fat Disorder

Summary: the purpose of this study is to evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat along the jawline with cryolipolysis.


Eligibility criteria:
inclusion criteria * male or female subjects \> 22 years of age and \< 65 years of age. * treatment area skin fold thickness \> 1cm (measured by caliper). * sufficient treatment area requiring at least 2 cooling cycles. * no weight change exceeding 5% of body weight in the preceding month. * agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study. * subject has signed a written informed consent form. exclusion criteria * excessive skin laxity in the treatment area for which reduction of subcutaneous fat may, in the opinion of the investigator, result in an unacceptable aesthetic result. * prominent platysmal bands at rest which may interfere with assessment of treatment area. * evidence of any cause of enlargement in the treatment area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands. * significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands. * treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the treatment area (below the mandible) within the past 6 months. * botulinum toxin or other aesthetic drug injections within the treatment area in the past 6 months. * history of facial nerve paresis or paralysis (such as bell's palsy). * history of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment. * history of prior neck surgery, or prior surgery in the area of intended treatment. * current infection in and adjacent to treatment area. * known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria. * known history of raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. * history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. * currently taking or has taken diet pills or weight control supplements within the past month. * any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation. * active implanted device such as a pacemaker, defibrillator, or drug delivery system. * pregnant or intending to become pregnant in the next 6 months. * lactating or has been lactating in the past 6 months. * unable or unwilling to comply with the study requirements. * currently enrolled in a clinical study of an unapproved investigational drug or device. * any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
fees to determine neurological intensive care patients' oral diet

Conditions: Dysphagia; Aspiration Pneumonia; Deglutition Disorders; Intensive Care Neurological Disorder

Summary: dysphagia is associated with high rates of mortality and morbidity. adjusting the oral diet of icu-patients based on flexible endoscopic evaluation of swallowing (fees) findings might reduce pneumonia rate, mortality and need for intubation/tracheotomy.

dysphagia, a common complication in neurological disorders, leads to high rates of mortality and morbidity. it is prevalent in critically ill patients, especially those who need mechanical ventilation. the investigators therefore investigate the effect of adjusting the oral diet of our intensive care unit (icu) patients based on flexible endoscopic evaluation of swallowing (fees) findings, thereby assessing the impact of fees on a neurological icu. all patients treated on the investigators neurological icu will be eligible for this study. the investigators will correlate findings with baseline data, disability status, pneumonia and duration of hospitalisation, as well as a need for mechanical ventilation or a tracheotomy.

Eligibility criteria:
inclusion criteria: * treatment on neurological icu * clinical suspicion of dysphagia exclusion criteria: * none

Keywords: dysphagia aspiration management of dysphagia deglutition disorders deglutition fees intensive care neurological disorder
effect of the home-based digital-assisted dyadic tai chi (hdtc) training program on cardiac function among sedentary individuals with hf and care burden of their caregivers: a randomized controlled trial

Conditions: Heart Failure (HF)

Summary: the proposed study aims to assess the effectiveness of the hdtc training program in improving cardiac function and secondary outcomes among sedentary heart failure individuals, while simultaneously reducing care burden and improving other outcomes for their caregivers.

this is a two-arm parallel, single-blinded randomized controlled trial. a total of 118 hf individuals and 118 caregivers will be enrolled and allocated to the hdtc group and the control group in a 1:1 ratio. participants in the control group will receive usual care. those in the hdtc group will also attend the hdtc training program, including a 30-minute educational seminar, a 1-hour dyadic coaching session, and 12-week tai chi training. data on cardiac function, exercise tolerance, exercise self-efficacy, fear of activity, sedentary behavior, hospital admission, health-related quality of life, depression, anxiety, stress, and mutuality for hf individuals, as well as care burden, quality of life, depression, anxiety, stress, and mutuality of caregivers, will be collected at baseline (t0), 4 weeks (t1) and 12 weeks (t2) after the intervention. the intention-to-treat analysis (itt), modified itt analysis, and per-protocol analysis will be conducted. the generalized estimating equation (gee) model will be used to measure changes in outcome variables.

Eligibility criteria:
inclusion criteria: * hf individuals: * aged 18 to 75 years * diagnosed with chf based on the chinese guidelines for diagnosis and treatment of heart failure 2024 * categorized as nyha class i, ii or iii * 6mwd \>150 meters (mild to moderate hf) * stable phase of disease in the past four weeks and capable of independently practice tai chi without any musculoskeletal disorders that may impede joint movement * sit more than 8 h/d in the past month * own a smartphone * volunteer to participate and provide informed consent. * caregivers: * age ≥18 years old * primary caregiver at home, who has emotional ties or social obligations with hf individuals and provides daily care * able to exercise tai chi without help * volunteer to participate and provide informed consent. exclusion criteria: * hf individuals: * plan to undergo surgery within the next 6 months * have severe comorbidities, such as cancer, liver or kidney failure, or diagnosed psychiatric disorders * plan to be admitted to a nursing home or other care facilities * regularly practice tai chi or engaging in other forms of exercise in the past 3 months (at least 3 times per week, at least 20 minutes of regular exercise each time) * currently participate in similar or related studies. * caregivers: · formal caregivers, such as nurses, will be excluded.

Keywords: heart failure tai chi dyadic cardiac function care burden
diabetic complications and obstructive sleep apnea

Conditions: Diabetic Complications and Obstructive Sleep Apnea

Summary: to follow up the progress of chronic complications in t2dm patients who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018.

obstructive sleep apnea (osa) is a common chronic sleep disorder and a frequent comorbidity in patients with type 2 diabetes. there has been increasing recognition that osa is highly prevalent in persons with type 2 diabetes. this study is to explore the relationship between osa and the progress of chronic diabetes-related complications in type 2 diabetes who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018 in the department of endocrinology and diabetes, the first affiliated hospital of xiamen university, xiamen, china.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * age：18-80 exclusion criteria: * patients with non type 2 diabetes mellitus * preparation for pregnancy * lactation patients * patients with uncontrolled thyroid disease * patients with severe cardiovascular disease * patients with severe hepatic and renal insufficiency * patients with oral and maxillofacial malformations and upper respiratory tract malformations * patients with pulmonary infection or copd * patients who are not willing to accept the questionnaire survey * unable to sign informed consent

Keywords: type 2 diabetes diabetic complications obstructive sleep apnea
safety study in relapsing-remitting multiple sclerosis (rrms) patients receiving betaferon or rebif

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: the purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either betaferon 250µg or rebif 44µg using different autoinjectors.

original french title of the study: etude de phase iv, multicentrique, randomisée, ouverte, comparant les réactions et la douleur aux sites d'injection après administration sous-cutanée d'interféron β-1b (betaferon®) ou interféron β-1a (rebif®) pendant la période de trois mois d'initiation de la thérapie chez des patients atteints d'une forme récurrente/rémittente de sclérose en plaques. the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer healthcare ag, germany. bayer healthcare ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * males or females * age \>= 18 years old * patients after a first demyelinating event suggestive of ms (only for betaferon) as well as patients with a definite diagnosis of rrms (betaferon et rebif) * first justified prescription of one interferon beta by subcutaneous route (as described in summary of product characteristics \[smpc\] of betaferon or rebif) * females of child-bearing potential must agree to practice adequate contraceptive methods over the duration of the study (not applicable for men) * patient can follow and comply with all study procedures of the trial protocol * laboratory evaluations (i.e., evaluation of hepatic enzyme gamma-gt, full blood count and differential white blood cell count \[wbc\]) must be available and the results must be normal. * written informed consent exclusion criteria: * any contraindication to the prescription of betaferon or rebif, as described in the smpc of products: * pregnancy or lactation * known hypersensitivity to natural or recombinant interferon beta, to mannitol, to human albumin or any other excipients used * history of severe depression or suicide attempt or current suicidal ideation. * patient with decompensated liver disease * epilepsy not adequately controlled by treatment * patient previously included in this study. * patient previously treated by sub-cutaneous route with either betaferon or rebif. * participation in any clinical trial within the past 30 days involving the investigational drug intake. * medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.

Keywords: multiple sclerosis rrms
phase 1 safety study of single and multi-dose topically applied olt1177 gel in healthy subjects

Conditions: Healthy Volunteers

Summary: the purpose of this study is to determine if olt1177 gel is safe and can be tolerated when given as a single dose and multidose to a defined area of one knee of healthy subjects.

olt1177 gel is being developed for the topical treatment of pain and inflammation emanating from musculoskeletal and certain skin inflammatory conditions. this is a phase 1 study evaluating the safety and tolerability of olt1177 gel in healthy subjects when given as single-dose or multi-dose applications. the study will be conducted in two parts, part a and part b. in part a, approximately 18 healthy subjects in 3 dose escalating cohorts will be randomized to receive a single dose of the investigational drug (5 subjects olt1177 gel and 1 subject placebo gel). upon completion of part a, a new subject population of approximately 18 subjects in 3 dose escalating cohorts will be randomized in part b of the study. subjects will receive a total of 8 doses over 3 consecutive days given 6 hours apart while awake during the day and will be followed for up to 30 days for safety assessment.

Eligibility criteria:
inclusion criteria: * healthy men and women 18 to 60 years of age * women of childbearing potential must have a negative urine pregnancy test within 3 days of study enrollment and must agree to use a highly effective form of contraception * subjects must be in good health as determined by the investigator based on medical history, ecg, physical examination and safety laboratory test * ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the investigator, to comply with all the requirements of the study exclusion criteria: * subjects with a known hypersensitivity to the investigational drug * subjects who are pregnant or lactating * participation in any investigational drug or device study and receipt of any investigational drug or device within the immediate 30 days prior to the start of this study * concurrent or recent use of analgesics, steroids, allergy medications, h2 blockers within 48 hours of the start of the study * subjects with a prior knee injury or surgery within the last 5 years * subjects with an active infection or with a fever ≥ 38°c within 3 days of the start of the study * subjects with a history of, or known to be positive for, hiv, hepatitis b or c * subjects with uncontrolled hypertension as defined by systolic blood pressure (sbp) \> 150 mm/hg, diastolic blood pressure (dbp) \> 100 mm/hg * subjects with a wound or skin irritation or any skin condition, e.g., psoriasis in the treatment area * subjects who are taking prescription medications with the exception of oral or systemic contraceptives * subjects who have systemic diseases * subjects who have a history of anaphylactic reactions to any systemic or topical compounds

Keywords: safety tolerability pharmacokinetics dose escalation randomized healthy volunteers topical olt1177 olatec pain inflammation
a multicenter, randomized, open, parallel-designed study to evaluate the efficacy and safety of hrs-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: a multicenter, randomized, open, parallel-designed phase ii study to evaluate the efficacy and safety of hrs-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis b.


Eligibility criteria:
inclusion criteria: 1. meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2; 2. chronic hepatitis b defined as hbv infection documented for at least 6 months prior to screening; 3. virologically suppressed on nucleoside or nucleotide analogues treatment with hbv dna below the lower limit of quantitation; 4. on commercially available nas monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization; 5. need to take effective contraceptive measures； 6. volunteer to sign an informed consent. exclusion criteria: 1. history of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis b that may affect the evaluation of the study; 2. with autoimmune disease; 3. history of solid organ transplantation or hematopoietic stem cell transplantation; 4. clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases; 5. malignant tumors were diagnosed within 5 years prior to randomization； 6. infection requiring intervention within 2 weeks prior to randomization; 7. major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results; 8. laboratory tests during the screening period were obviously abnormal; 9. prolonged ecg qtcf or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period; 10. history of drug use, alcohol or drug abuse in the 12 months prior to randomization; 11. participated in clinical study of other drugs (received experimental drugs); 12. pregnant or nursing women; 13. allergic to a drug ingredient or component; 14. other reasons for ineligibility as judged by the investigators.
artificial intelligence versus human-controlled doctor in virtual reality simulation for sepsis team training

Conditions: Sepsis

Summary: the purpose of the study is to compare the effectiveness of artificial intelligence virtual doctor with human-controlled virtual doctor avatars on nursing students' sepsis care and interprofessional communication.


Eligibility criteria:
inclusion criteria: 1. all year 3 nus nursing students in academic year 2022 2. individuals 20 years old and above; and 3. consent to be video and/or audio-recorded exclusion criteria: 1. year 1, 2 and 4 nus nursing students; 2. incapable of giving informed consent; 3. unable to understand and/or speak in english language; 4. have visual, speech, and/or hearing impairment; and 5. do not agree to be video and/or audio-recorded.

Keywords: artificial intelligence team training virtual reality simulation health care education
gastrointestinal motility in patients with neuroendocrine tumors

Conditions: Neuroendocrine Tumor

Summary: we will study the total gastrointestinal transit time (gitt), gastric emptying and small intestine motility in net patients before and after treated with somatostatin analogues and compare these to healthy subjects. for this we will use radio-opaque markers and the newly developed motility tracking system (mts). hypothesis: patients with net and carcinoid syndrome have decreased gitt, gastric emptying and small bowel transit time and an increase in phase iii mmc activity compared to healthy subjects. treatment with somatostatin analogues increase transit times and decrease phase iii mmc activity and improves the clinical symptoms.


Eligibility criteria:
inclusion criteria: * net confirmed by histology * diarrhea, (at least 3 loose or watery bowel movements per day) as part of carcinoid syndrome. * newly referred patients without previous somatostatin analogue treatment or * net patients who are pausing somatostatin analogue treatment due to other treatment or examination. exclusion criteria: * subjects unable to understand the information * severe diabetes with late complications or known metabolic disorder * inflammatory bowel disease * known clinically significant stenosis of the bowel * bile acid malabsorption due to intestinal surgery * small bowl bacterial overgrowth

Keywords: neuroendocrine tumor carcinoid syndrome motility transit time
safety and efficacy of bepotastine besilate nasal spray in the treatment of seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: this is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.


Eligibility criteria:
inclusion criteria: * male or female at least 12 years of age with a history of mountain cedar allergy exclusion criteria: * no active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
24-week efficacy & safety study of brisdelle™ (formerly known as mesafem) in the treatment of vasomotor symptoms

Conditions: Hot Flashes

Summary: to assess the safety and efficacy of brisdelle (paroxetine mesylate) capsules 7.5 mg for treatment of vasomotor symptoms (vms) associated with menopause

the study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of brisdelle (paroxetine mesylate) capsules 7.5 mg in subjects with moderate to severe postmenopausal vms, defined as follows: 1. moderate vms: sensation of heat with sweating, able to continue activity 2. severe vms: sensation of heat with sweating, causing cessation of activity the study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Eligibility criteria:
inclusion criteria: 1. female, \>40 years of age 2. reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior 3. spontaneous amenorrhea for at least 12 consecutive months 4. amenorrhea for at least 6 months and meet the biochemical criteria for menopause 5. bilateral salpingo-oophorectomy \>6 weeks with or without hysterectomy exclusion criteria: 1. bmi ≥ 40 kg/m² 2. known non-responder to previous selective serotonin reuptake inhibitor (ssri) or serotonin norepinephrine reuptake inhibitor (snri) treatment for vms 3. history of self-injurious behavior 4. history of clinical diagnosis of depression; or treatment for depression 5. history of clinical diagnosis of borderline personality disorder 6. use of an investigational study medication within 30 days prior to screening or during the study 7. concurrent participation in another clinical trial or previous participation in this trial 8. family of investigational-site staff

Keywords: vasomotor symptoms menopause hot flashes perimenopause nonhormonal therapies climacteric symptoms mesafem low-dose mesylate salt of paroxetine (ldmp)
a first in human study to assess safety, tolerability, pharmacokinetics of abi-4334 in healthy subjects

Conditions: Chronic Hepatitis B

Summary: this study is designed to assess safety, tolerability, and pk of single ascending doses (sad) of abi-4334 in part a and multiple-ascending doses (mad) of abi-4334 in part b in healthy subjects. effect of food will also be evaluated in part a.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.0 and 30.0 kg/m2 * in good health (as determined by the investigator) based on medical history, physical examination, ecg, and clinical laboratory results. * female subjects must be non-pregnant and have a negative serum pregnancy test at screening and a negative urine pregnancy test at day 1 * agreement to comply with protocol-specified contraceptive requirements exclusion criteria: * positive results for any of the following serology tests, hbsag, hepatitis b core antibody (hbcab igm), hepatitis c virus antibody (hcv ab), or hiv-1 or -2 antibody * history of any illness that, in the opinion of the investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or a condition known to interfere with the absorption/ distribution/elimination of drugs. * history of any significant drug-related allergic reactions such as anaphylaxis, stevens-johnson syndrome, urticaria, or multiple drug allergies * history of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening * has participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months before screening

Keywords: abi-4334 pk healthy subjects